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First Approach for Aspirin Misuse Objective Screening (FirstAMOS)

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Laser speckle flowmetry

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

subjects referred for investigation of peripheral arterial disease.
Affiliation to the French National healthcare system
French speaking patients
Ability to stand still for half a minute.

Exclusion Criteria:

pregnancy
inability to understand the study goal
Patients protected by decision of law

Sites / Locations

UH Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAD patients

Arm Description

Patients referred for vascular ultrasound investigation for suspicion of peripheral artery disease (PAD). Intervention is measurement of microvascular response to current application on the skin by Laser speckle flowmetry

Outcomes

Primary Outcome Measures

correlation of treatments to CIV response.

Classification of drugs in drug type categories. encoding in 1 (presence) or 0 ug (absence) of the drug category in the usual treatment of the patient. Multiple regression analysis of the different drug categories as factors influencing the increase in skin blood flow after CIV.

Secondary Outcome Measures

Full Information

NCT ID

NCT02997436

First Posted

December 6, 2016

Last Updated

October 30, 2017

Sponsor

University Hospital, Angers

1. Study Identification

Unique Protocol Identification Number

NCT02997436

Brief Title

First Approach for Aspirin Misuse Objective Screening

Acronym

FirstAMOS

Official Title

Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : "ASA-test. A New Tool for the Screening of Aspirin Treatment")

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 4, 2017 (Actual)

Primary Completion Date

April 10, 2017 (Actual)

Study Completion Date

April 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Angers

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

Detailed Description

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description. Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PAD patients

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Laser speckle flowmetry

Intervention Description

A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes. Microvascular response to current application (CIV) will be recorded by laser speckle flowmetry 10 minutes later. Measurement of the value of skin blood flow (by laser speckle) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded

Primary Outcome Measure Information:

Title

correlation of treatments to CIV response.

Description

Time Frame

10 minutes after the second period of current application

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subjects referred for investigation of peripheral arterial disease. Affiliation to the French National healthcare system French speaking patients Ability to stand still for half a minute. Exclusion Criteria: pregnancy inability to understand the study goal Patients protected by decision of law

Overall Study Officials: